Identity
- Trade Name
- Dyna Locking Trochanteric Nail FDA UDI
- Generic Name
- Bone-nailing compression screw FDA UDI
- Model / Reference
- NGS1037 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800015949804 FDA UDI
- FDA Product Code
- HWN FDA UDI
- GMDN Term
- Bone-nailing compression screw FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-nailing compression screw
Dyna Locking Trochanteric Nail by CG MedTech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-nailing compression screw.
- ELOS INSTRUMENTS — INTRAUMA SPA · Class II
- 3.0mm Compression Tool — INTERVENTIONAL SPINE, INC · Class I
- REDUCTION BOLT, TIBIAL INSERTION GUIDE, SUPRAPATELLAR — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- ELOS INSTRUMENTS — INTRAUMA SPA · Class II
- Compressor — Orthopedic Designs North America, Inc. · Class I
- Compression Tool with Tray — INTERVENTIONAL SPINE, INC · Class I
- REDUCTION BOLT, EXTENDED TIBIAL INSERTION GUIDE — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CG MedTech Co., Ltd.
Sources (1)
- FDA UDI ec785270-620c-4b1f-8c1c-c9d81eb92465 33 fields · synced May 29, 2026